Remel, Inc: Device Recall

Recall #Z-1947-2025 · 05/01/2025

Class II: Risk

Recall Details

Recall Number: Z-1947-2025
Classification: Class II
Product Type: Device
Recalling Firm: Remel, Inc
Status: Ongoing
Date Initiated: 05/01/2025
Location: Lenexa, KS, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 70 units

Reason for Recall

Product may have an off color affecting perfomance

Product Description

Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic device

Distribution Pattern

Worldwide - US Nationwide distribution in the states of AL, GA, KY, VA and the countries of Canada, UK.

Other Recalls by Remel, Inc

Class II: Risk 11/12/2025

Products may contain contamination, which may result in a darker or brown media color.
Class II: Risk 07/11/2025

The products may contain surface and subsurface contamination of Listeria monocytogenes.
Class II: Risk 07/11/2025

The products may contain surface and subsurface contamination of Listeria monocytogenes.
Class II: Risk 07/11/2025

The products may contain surface and subsurface contamination of Listeria monocytogenes.
Class II: Risk 07/11/2025

The products may contain surface and subsurface contamination of Listeria monocytogenes.

View all recalls by Remel, Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.